To the Editor: While I generally
agree with the advocacy position taken by Mr Moore and
colleagues1 that more resources be
committed to the
postmarketing surveillance of adverse drug events (ADEs) occurring with
the use of marketed medications and other treatments, most of their
suggestions are based on hyperbole and not on an appreciation of the
principles or difficulties of surveillance. Consider their suggestion
that the Food and Drug Administration (FDA) enumerate or estimate
drug-induced disease and deaths much as the National Highway
Transportation Safety Administration and Federal Aviation
Administration (FAA) track motor vehicle and airplane crashes and
deaths. Although this sounds rational and easy, it is unclear exactly
how a drug-induced clinical event should be defined, especially since
most events of interest are not particularly specific to a single drug
or population. Whereas judging a death in an automobile crash as being
caused by the crash is correct almost all the time, clinical judgment
about the cause of clinical events will not have sufficient predictive
value to provide meaningful estimates. The inescapable fact is that an
accurate estimation of the extent of event occurrence that is
attributable to drugs and treatments will require control groups and a
massive expenditure of resources. Such effort is not necessary with
attributing deaths to automobile or airplane crashes because few deaths
that occur during crashes are attributable to causes other than the
crash.